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Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years

Primary Purpose

Post Operative Pain, Analgesia, Children, Only

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
NIPE monitor
Control
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

1 Month - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newborn up to 2 years old ASA Status 1-2 Undergoing elective surgery of upper part of body Exclusion Criteria: Premature Arrhythmia Concomitant use of regional anesthesia Plan for ICU admission

Sites / Locations

  • Faculty of Medicine, Khon Kaen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group NIPE

Group Control

Arm Description

Intraoperative fentanyl administration will be guided by NIPE protocol

Intraoperative fentanyl administration will be guided by clinical signs

Outcomes

Primary Outcome Measures

Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
Assess pain using a FLACC score every 15 minutes. FLACC has a range from 0 to 10 with 0 indicates no pain while 10 indicates worst pain. NRS of 0-3 is mild, 4-6 is moderate, and 7-10 is severe pain.

Secondary Outcome Measures

Postoperative fentanyl consumption
Fentanyl administration in PACU
Postoperative sedation score
Sedation score (0-3; higher scores mean a worse outcome) in PACU

Full Information

First Posted
February 23, 2023
Last Updated
April 12, 2023
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT05758090
Brief Title
Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years
Official Title
Comparison of Newborn Infant Parasympathetic Evaluation (NIPE) Index Versus Standard Hemodynamic Response for Guiding Intraoperative Fentanyl Administration in Children Younger Than 2 Years Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 10, 2023 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
During general anesthesia, objective monitoring for analgesia is still lacking. The administration of opioids relies on the experience of the anesthesiologist. There are some monitors, e.g., Analgesia Nociception Index (ANI), showing that they can evaluate analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor was released for assessing analgesia in children with age less than 2 years. The investigators aim to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.
Detailed Description
During balanced anesthesia, hypnosis can be monitored with BIS, muscle relaxation can be monitored with a train-of-four, however, analgesia lacks precise monitoring. The anesthesiologist administers narcotics according to clinical signs and experience. Analgesia Nociception Index (ANI) has been introduced as an objective monitor for analgesia in adults. Recently, a Newborn Infant Parasympathetic Evaluation (NIPE) monitor has been introduced to assess analgesia in children under 2 years, however, clinical studies regarding its clinical efficacy are scarce. The objective of this study is to assess the efficacy of NIPE as a guide for intraoperative fentanyl administration in children under 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Analgesia, Children, Only, Narcotic Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group NIPE
Arm Type
Experimental
Arm Description
Intraoperative fentanyl administration will be guided by NIPE protocol
Arm Title
Group Control
Arm Type
Placebo Comparator
Arm Description
Intraoperative fentanyl administration will be guided by clinical signs
Intervention Type
Procedure
Intervention Name(s)
NIPE monitor
Intervention Description
Procedure/Surgery: NIPE protocol. Give intraoperative fentanyl according to NIPE value. NIPE score 50-70 indicates optimal narcotic effect. NIPE score > 70 indicated overdosage of narcotic and narcotic should be withheld. NIPE score < 50 indicates inadequate narcotic and narcotic should be given.
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Procedure/Surgery: Standard protocol. Give intraoperative fentanyl according to vital signs.
Primary Outcome Measure Information:
Title
Postoperative pain: Face, Legs, Activity, Cry, Consolability scale (FLACC scale)
Description
Assess pain using a FLACC score every 15 minutes. FLACC has a range from 0 to 10 with 0 indicates no pain while 10 indicates worst pain. NRS of 0-3 is mild, 4-6 is moderate, and 7-10 is severe pain.
Time Frame
During 120 minutes in PACU
Secondary Outcome Measure Information:
Title
Postoperative fentanyl consumption
Description
Fentanyl administration in PACU
Time Frame
During 120 minutes in PACU
Title
Postoperative sedation score
Description
Sedation score (0-3; higher scores mean a worse outcome) in PACU
Time Frame
During 120 minutes in PACU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newborn up to 2 years old ASA Status 1-2 Undergoing elective surgery of upper part of body Exclusion Criteria: Premature Arrhythmia Concomitant use of regional anesthesia Plan for ICU admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thepakorn Sathitkarnmanee, MD
Phone
66-81-9547622
Email
thepakorns@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sirirat Tribuddharat, MD, PhD
Phone
66-81-6205920
Email
sirirat.tribuddharat@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirirat Tribuddharat, MD, PhD
Organizational Affiliation
Khon Kaen University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Medicine, Khon Kaen University
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thepakorn Sathitkarnmanee, MD
Phone
+66819547622
Email
thepakorns@gmail.com
First Name & Middle Initial & Last Name & Degree
Sirirat Tribuddharat, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30793426
Citation
Weber F, Roeleveld HG, Geerts NJE, Warmenhoven AT, Schroder R, de Leeuw TG. The heart rate variability-derived Newborn Infant Parasympathetic Evaluation (NIPE) Index in pediatric surgical patients from 0 to 2 years under sevoflurane anesthesia-A prospective observational pilot study. Paediatr Anaesth. 2019 Apr;29(4):377-384. doi: 10.1111/pan.13613. Epub 2019 Mar 21.
Results Reference
result
PubMed Identifier
33590418
Citation
Recher M, Boukhris MR, Jeanne M, Storme L, Leteurtre S, Sabourdin N, De Jonckheere J. The newborn infant parasympathetic evaluation in pediatric and neonatology: a literature review. J Clin Monit Comput. 2021 Oct;35(5):959-966. doi: 10.1007/s10877-021-00670-8. Epub 2021 Feb 15.
Results Reference
result
PubMed Identifier
33329766
Citation
Lim BG. Nociception monitoring tools using autonomic tone changes for intraoperative analgesic guidance in pediatric patients. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):380-392. doi: 10.17085/apm.2019.14.4.380.
Results Reference
result
PubMed Identifier
31185928
Citation
Zhang K, Wang S, Wu L, Song Y, Cai M, Zhang M, Zheng J. Newborn infant parasympathetic evaluation (NIPE) as a predictor of hemodynamic response in children younger than 2 years under general anesthesia: an observational pilot study. BMC Anesthesiol. 2019 Jun 11;19(1):98. doi: 10.1186/s12871-019-0774-y.
Results Reference
result

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Newborn Infant Parasympathetic Evaluation (NIPE) for Guiding Intraoperative Fentanyl in Children Under 2 Years

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